Short-term Efficacy of Antidepressant in Patients Underwent TKA

Phase 1

• Conditions: Osteoarthritis Of Knee
• Interventions: Drug: Duloxetine Hydrochloride

• Registration Number: NCT03110172
• Lead Sponsor: Dalian Municipal Central Hospital

Brief Summary

By taking certain antidepressant in early postoperative period，which is supposed to improve the psychological status of patients with osteoarthritis, explore the effect of certain antidepressant on the recovery of the early stage after the operation of knee joint replacement.

Detailed Description

In this study, the investigators are going to investigate the efficacy of Duloxetine on pain, physical function, mental health and quality of life in patients underwent TKAs.

The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation.On the basis of the above scheme, the treatment group is going to receiving duloxetine 60mg/24h to 8 weeks after operation.HAMD-17 scale, KSS scale, SF-36 scale and WOMAC scale will be used to evaluate the two groups before and after operation for 4 and 8 weeks.

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-14
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria
2. Primary TKA surgery,Varus is smaller than 20°
3. Always there is no history of mental illness, no history of relevant medicine
4. Be able to read and understand Chinese, with good communication skills
5. Voluntary participation in this clinical study

Exclusion Criteria

1. Previous history of mental and psychological illness
2. With severe diseases in respiratory system, circulatory system or digestive system
3. Allergic to duloxetine and celecoxib

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAMD-17 scale	Duloxetine Hydrochloride	Hamilton Depression Score with Duloxetine Hydrochloride
SF-36 scale	Duloxetine Hydrochloride	Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride
WOMAC scale	Duloxetine Hydrochloride	Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride
KSS scale	Duloxetine Hydrochloride	Knee Society Score with Duloxetine Hydrochloride

Primary Outcome Measures

Name	Time	Method
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment.	up to 6 months	A face-to-face questionnaire will be conducted by two trained interviewers
Function score of participants with Duloxetine as assessed by Knee Society Score after 4 weeks of treatment.	up to 6 months	A face-to-face questionnaire will be conducted by two trained interviewers

Secondary Outcome Measures

Name	Time	Method
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment.	up to 6 months	A face-to-face questionnaire will be conducted by two trained interviewers
Function score of participants with Duloxetine as assessed by Knee Society Score after 8 weeks of treatment.	up to 6 months	A face-to-face questionnaire will be conducted by two trained interviewers

Trial Locations

Locations (1)

Dalian municipal central hospital; 🇨🇳 Dalian, Liaoning, China